[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.180]

[Page 247]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
   Subpart G_Production and Process Control System: Requirements for 
 Components, Packaging, and Labels and for Product That You Receive for 
              Packaging or Labeling as a Dietary Supplement
 
Sec.  111.180  Under this subpart G, what records must you make and keep?

    (a) You must make and keep records required under this subpart G in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart.
    (2) Receiving records (including records such as certificates of 
analysis, suppliers' invoices, and suppliers' guarantees) for 
components, packaging, and labels and for products that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier); and
    (3) Documentation that the requirements of this subpart were met.
    (i) The person who performs the required operation must document, at 
the time of performance, that the required operation was performed.
    (ii) The documentation must include:
    (A) The date that the components, packaging, labels, or products 
that you receive for packaging or labeling as a dietary supplement were 
received;
    (B) The initials of the person performing the required operation;
    (C) The results of any tests or examinations conducted on 
components, packaging, or labels, and of any visual examination of 
product that you receive for packaging or labeling as a dietary 
supplement; and
    (D) Any material review and disposition decision conducted on 
components, packaging, labels, or products that you receive for 
packaging or labeling as a dietary supplement.